PEPCID DUO Milligram Tablets Chewable

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

FAMOTIDINE, MAGNESIUM HYDROXIDE, CALCIUM CARBONATE

Beschikbaar vanaf:

McNeil Healthcare (Ireland) Ltd

ATC-code:

A02BA03

INN (Algemene Internationale Benaming):

FAMOTIDINE, MAGNESIUM HYDROXIDE, CALCIUM CARBONATE

Dosering:

Milligram

farmaceutische vorm:

Tablets Chewable

Prescription-type:

Product not subject to medical prescription

Therapeutisch gebied:

H2-receptor antagonists

Autorisatie-status:

Authorised

Autorisatie datum:

2011-01-21

Bijsluiter

PEPCID DUO CHEWABLE TABLETS
Famotidine 10 mg, magnesium hydroxide 165 mg, calcium carbonate 800 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.

You must talk to your doctor if you do not feel better or if you feel
worse after 2 weeks.
WHAT IS IN THIS LEAFLET?
1.
What Pepcid Duo is and what it is used for
2.
What you need to know before you take Pepcid Duo
3.
How to take Pepcid Duo
4.
Possible side effects
5.
How to store Pepcid Duo
6.
Contents of the pack and other information
1.WHAT PEPCID DUO IS AND WHAT IT IS USED FOR
Pepcid Duo is for short-term treatment of the symptoms of heartburn
and acid indigestion in adults
and adolescents over the age of 16 years.
The tablets contain three active ingredients:

Famotidine is a medicine called n ‘H2 blocker’. It reduces acid
production in your stomach.

Magnesium hydroxide and calcium carbonate are ‘antacids’. They
neutralise the acid in your
stomach.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEPCID DUO
DO NOT TAKE PEPCID DUO IF:

You are allergic to famotidine, magnesium hydroxide, calcium carbonate
or any of the other
ingredients of this medicine (listed in section 6)

You have severe kidney problems.

You are allergic to other H2 blockers (medicines which control the
production of excess
stomach acid). WARNING AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Pepcid Duo if you
have:

Indigestion and have also lost weight involuntarily.

Stomach pain which does not go away.

Indigestion for the first time, or if your symptoms have recently
changed.

Too much calcium i

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pepcid Duo Chewable Tablets
Famotidine 10mg
Magnesium Hydroxide 165mg
Calcium Carbonate 800mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Famotidine 10.00 mg
Magnesium hydroxide 165.00 mg
Calcium carbonate 800.00 mg
Excipients: with known effect
_Lactose monohydrate, sucrose and glucose._
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Rose coloured, round, flat chewable tablet embossed with P.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term symptomatic treatment of heartburn or acid regurgitations
in adults and adolescents from 16 years old.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOR ADULTS AND ADOLESCENTS (from 16 years old).
Chew one tablet thoroughly when symptoms occur, and swallow preferably
with a glass of water. Do not exceed 2
tablets per day.
Treatment duration is limited to 2 weeks, unless with physician’s
advice (see section 4.4 Special warnings and
Precautions for use).
Paediatric population
The safety and efficacy of Pepcid Duo in children under 16 years of
age has not
yet
been established (no data are
available).
Elderly
No dosage adjustment is required for the elderly.
Renal Impairment
This medicine is contraindicated in patients with severe renal failure
(see section 4.3 Contraindications).
Patients with renal
impairment
should consult
their physician before taking famotidine/antacid combination (Please
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